A Phase 1 interventional study of AZD4205 and Placebo in Healthy Volunteers, sponsored by Dizal Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Dizal Pharmaceuticals · Phase 1, Interventional, and Treatment
This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.
Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days
Drug: AZD4205
placebo single dose in SAD and once daily for 14 days
Drug: Placebo
SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days
Single dose in SAD and once daily for 14 days
The number of subjects with adverse events
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs)
Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
The number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters
Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
The number of subjects with abnormal vital signs
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs
Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
The number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram
Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Dizal Pharmaceuticals